New products with claimed medical applications need to clear FDA hurdles to be marketed and sold in the U.S. Products that purport to measure biomarkers with previously untested technologies face extra scrutiny. Photoplethysmography (PPG) is an optical technique used to detect blood volume with measurements of the skin surface. PPG is a non-contact method used by various companies to measure heart rate, blood pressure, sleep efficiency, and more. While heart rate measures are well accepted, the use of the technology for other body metrics such as blood pressure remains controversial.
Brussels-based Qompium, recently received FDA clearance for FibriCheck, a medical smartphone and smartwatch application that uses PPG with artificial intelligence (AI) to detect atrial fibrillation. According to Qompium, FibriCheck is the first FDA-approved app to detect heart rhythm disorders without an external medical device. FibriCheck uses the smartphone camera or smartwatch optical sensors to detect heartbeats and derive the heart rhythm. According to the company, documents submitted to the FDA demonstrated that FibriCheck achieved equal accuracy results to the latest external devices that connect to smartphones with two electrodes to record single-lead ECGs.
FibriCheck received European Class IIa clearance in 2016 and recently opened a San Francisco office to prepare for the U.S. market. Now with FDA clearance, Qompium expects to bring Fibricheck to market in early 2019.